• Collaboration with the US Department of Defense’s largest military health organization underway

SAN ANTONIO / Apr 24, 2024 / Business Wire / bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on the need for noninvasive, accurate tests for the detection of early-stage lung cancer and other lung diseases, today announced David Elzi, Ph.D., has been named Vice President of Product Development to accelerate the development of new diagnostics based on the proprietary technology platform behind CyPath® Lung, the Company’s commercial test for the detection of early-stage lung cancer.

“As commercialization of CyPath® Lung continues to meet or exceed our projections, new products that will improve patients’ lives are an essential part of our growth strategy, which is focused on expanding our portfolio of solutions for detecting serious lung health issues at an early stage when treatment can positively impact prognosis,” said bioAffinity Technologies President and CEO Maria Zannes. “Dr. Elzi has led our research team for eight years, helping to bring CyPath® Lung to commercialization and now advancing two promising diagnostic products in the development phase.”

Both tests under development will use the Company’s flow cytometry and artificial intelligence platform to analyze patient samples that come from the lung. One test in development analyzes bronchoalveolar lavage (BAL) fluid to identify cancer-predictive cell populations and is intended for use as a companion to bronchoscopy, a more invasive procedure used with patients who have a higher likelihood of lung cancer.

The second test under development analyzes sputum to improve detection of chronic obstructive pulmonary disease (COPD). COPD is an inflammatory lung disease that causes breathing-related problems and irreversible airflow obstruction for an estimated 16 million Americans, according to the Centers for Disease Control.

The research on both BAL and sputum samples for lung cancer and COPD is part of a collaboration between bioAffinity Technologies and the Fort Sam Houston Brooke Army Medical Center (BAMC), the largest military health organization within the Department of Defense (DOD).

BAMC is currently enrolling DOD beneficiaries at high risk for developing lung cancer in a prospective observational study (NCT05870592) to address whether DOD beneficiaries at high risk for lung cancer may have an alternative to annual low dose computed tomography (LDCT) screening and whether CyPath^® Lung can help predict cancerous lung nodules prior to more invasive procedures such as biopsy. Michael J. Morris, M.D., BAMC pulmonology physician and Assistant Dean of Research at San Antonio Uniformed Services Health Education Consortium (SAUSHEC), is the Principal Investigator for the observational study.

Dr. Elzi earned his Ph.D. in Molecular and Cellular Biology from the University of Washington, in conjunction with the Fred Hutchinson Cancer Research Center. He subsequently performed post-doctoral research at the Bonfils Blood Center and University of Colorado Department of Surgery, where he studied the molecular mechanisms of transfusion-related lung injury. Prior to joining bioAffinity Technologies in 2016, he was a research scientist at the Greehey Children’s Cancer Research Institute, The University of Texas Health Science Center at San Antonio, where his research included applying proteomic techniques to study cellular senescence in primary and cancer cells.

About CyPath® Lung

CyPath^® Lung uses proprietary advanced flow cytometry and artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. Automated data analysis helps determine if cancer is present or if the patient is cancer-free. CyPath® Lung incorporates a fluorescent porphyrin, meso-tetra (4-carboxyphenyl) porphyrin (TCPP), that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated that CyPath® Lung had 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small lung nodules less than 20 millimeters. Diagnosing and treating early-stage lung cancer can improve outcomes and increase patient survival. For more information, visit www.cypathlung.com.

About bioAffinity Technologies, Inc.

bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and diseases of the lung and broad-spectrum cancer treatments. The Company’s first product, CyPath^® Lung, is a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies. For more information, visit www.bioaffinitytech.com and follow us on LinkedIn, Facebook and X.

Forward-Looking Statements

Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are based upon current estimates and assumptions and include statements regarding CyPath® Lung continuing to meet or exceed Company projections, the expected contribution of Dr. Elzi, and new tests under development using the Company’s flow cytometry and artificial intelligence platform to analyze patient samples for COPD and as a companion to bronchoscopy. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the ability of CyPath® Lung to continue to meet or exceed the Company’s projections, the tests performing as anticipated and having favorable results, the contributions to be derived from Dr. Elzi and the other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, and its subsequent filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. While the Company believes these forward-looking statements are reasonable, readers of this press release are cautioned not to place undue reliance on any forward-looking statements. The information in this release is provided only as of the date of this release, and the Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws.